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FDA Approves Xtoro for Acute Otitis Externa

To treat infections caused by Pseudomonas aeruginosa and Staphylococcus aureus

THURSDAY, Dec. 18, 2014 (HealthDay News) -- Xtoro (finafloxacin otic suspension) eardrops have been approved by the U.S. Food and Drug Administration to treat acute otitis externa.

This new treatment has been approved for acute otitis externa caused by Pseudomonas aeruginosa and Staphylococcus aureus, and is the latest fluoroquinolone antimicrobial medication to be approved by the FDA. It joins several other antibacterial drug products previously approved to treat ear infections, the FDA said in a news release.

Xtoro's safety and effectiveness were evaluated in a clinical study of 1,234 people, aged 6 months to 85 years, assigned to either the medication or vehicle (a solution without a fluoroquinolone). Seventy percent of patients who received Xtoro achieved clinical cure, compared to 37 percent who received the vehicle. The most common side effects were ear itching and nausea.

"The availability of multiple treatment options allows physicians and patients to find the treatment to meet their needs," Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in the news release.

Xtoro is produced by Alcon Laboratories, based in Fort Worth, Texas.

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